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... 8. Special account should be taken of the potential impact of this Regulation on small- and medium-sized enterprises (SMEs) and the need to avoid any discrimination against them. ...

... 31. The Commission, in close cooperation with industry, Member States and other relevant stakeholders, should develop guidance to fulfil the requirements under this Regulation related to preparations (in particular with regard to safety data sheets incorporating exposure scenarios) including assessment of substances incorporated into special preparations – such as metals incorporated in alloys. In doing so, the Commission should take full account of the work that will have been carried out within the framework of the RIPs and should include the necessary guidance on this matter in the overall REACH guidance package. This guidance should be available before the application of this Regulation. ...

... 35. The Member States, the Agency and all interested parties should take full account of the results of the RIPs, in particular with regard to the registration of substances which occur in nature. ...

... 36. It is necessary to consider the application of Article 2(7)(a) and (b) and Annex XI to substances derived from mineralogical processes and the review of Annexes IV and V should fully take this into account. ...

... 62. Communication up and down the supply chain should be facilitated. The Commission should develop a system categorising brief general descriptions of uses taking into account the outcomes of the RIPs. ...

... 64. In order to prevent unnecessary animal testing, interested parties should have a period of 45 days during which they may provide scientifically valid information and studies that address the relevant substance and hazard end-point, which is addressed by the testing proposal. The scientifically valid information and studies received by the Agency should be taken into account for decisions on testing proposals. ...

... 69. To ensure a sufficiently high level of protection for human health, including having regard to relevant human population groups and possibly to certain vulnerable sub-populations, and the environment, substances of very high concern should, in accordance with the precautionary principle, be subject to careful attention. Authorisation should be granted where natural or legal persons applying for an authorisation demonstrate to the granting authority that the risks to human health and the environment arising from the use of the substance are adequately controlled. Otherwise, uses may still be authorised if it can be shown that the socio-economic benefits from the use of the substance outweigh the risks connected with its use and there are no suitable alternative substances or technologies that are economically and technically viable. Taking into account the good functioning of the internal market it is appropriate that the Commission should be the granting authority. ...

... 71. Methodologies to establish thresholds for carcinogenic and mutagenic substances may be developed taking into account the outcomes of RIPs. The relevant Annex may be amended on the basis of these methodologies to allow thresholds where appropriate to be used while ensuring a high level of protection of human health and the environment. ...

... 73. Substitution of a substance on its own, in a preparation or in an article should be required when manufacture, use or placing on the market of that substance causes an unacceptable risk to human health or to the environment, taking into account the availability of suitable safer alternative substances and technologies, and the socio-economic benefits from the uses of the substance posing an unacceptable risk. ...

... 76. Experience at international level shows that substances with characteristics rendering them persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate, present a very high concern, while criteria have been developed allowing the identification of such substances. For certain other substances concerns are sufficiently high to address them in the same way on a case-by-case basis. The criteria in Annex XIII should be reviewed taking into account the current and any new experience in the identification of these substances and if appropriate, be amended with a view to ensuring a high level of protection for human health and the environment. ...

... 81. In order to provide a harmonised approach to the authorisation of the uses of particular substances, the Agency should issue opinions on the risks arising from those uses, including whether or not the substance is adequately controlled and on any socio-economic analysis submitted to it by third parties. These opinions should be taken into account by the Commission when considering whether or not to grant an authorisation. ...

... 107. The Agency should be financed partly by fees paid by natural or legal persons and partly by the general budget of the European Communities. The Community budgetary procedure should remain applicable as far as any subsidies chargeable to the general budget of the European Communities are concerned. Moreover, the auditing of accounts should be undertaken by the Court of Auditors in accordance with Article 91 of Commission Regulation (EC, Euratom) No 2343/2002 of 23 December 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities⁽¹²⁾107. . ...

... 109. The Agency should contribute, through cooperation with organisations having interests in the harmonisation of international regulations, to the role of the Community and the Member States in such harmonisation activities. To promote broad international consensus the Agency should take account of existing and emerging international standards in the regulation of chemicals such as the Globally Harmonised System (GHS) of classification and labelling of chemicals. ...

... 114. To ensure a harmonised protection for the general public, and, in particular, for persons who come into contact with certain substances, and the proper functioning of other Community legislation relying on the classification and labelling, an inventory should record the classification in accordance with Directive 67/548/EEC and Directive 1999/45/EC agreed by manufacturers and importers of the same substance, if possible, as well as decisions taken at Community level to harmonise the classification and labelling of some substances. This should take full account of the work and experience accumulated in connection with the activities under Directive 67/548/EEC, including the classification and labelling of specific substances or groups of substances listed in Annex I of Directive 67/548/EEC. ...

... 8. The Agency shall forthwith communicate any draft decisions to the competent authorities of each Member State in which the manufacture, import, production or product and process orientated research takes place. When taking decisions as provided for in paragraphs 4 and 7, the Agency shall take into account any comments made by such competent authorities. ...

... 2. A registrant shall submit to the Agency an update of the registration containing the information required by the decision made in accordance with Articles 40, 41 or 46 or take into account a decision made in accordance with Articles 60 and 73, within the deadline specified in that decision. The Agency shall notify the competent authority of the relevant Member State that the information is available on its database. ...

... 2. Information relating to testing proposals involving tests on vertebrate animals shall be published on the Agency website. The Agency shall publish on its website the name of the substance, the hazard end-point for which vertebrate testing is proposed, and the date by which any third party information is required. It shall invite third parties to submit, using the format provided by the Agency, scientifically valid information and studies that address the relevant substance and hazard end-point, addressed by the testing proposal, within 45 days of the date of publication. All such scientifically valid information and studies received shall be taken into account by the Agency in preparing its decision in accordance with paragraph 3. ...

... 3. In cases where two or more Member States have expressed an interest in evaluating the same substance and they cannot agree who should be the competent authority, the competent authority for the purposes of Articles 46, 47 and 48 shall be determined in accordance with the following procedure. The Agency shall refer the matter to the Member State Committee, in order to agree which authority shall be the competent authority, taking into account the Member State in which the manufacturer(s) or importer(s) is located, the respective proportions of total Community gross domestic product, the number of substances already being evaluated by a Member State and the expertise available. If, within 60 days of the referral, the Member State Committee reaches unanimous agreement, the Member States concerned shall adopt substances for evaluation accordingly. If the Member State Committee fails to reach a unanimous agreement, the Agency shall submit the conflicting opinions to the Commission, which shall decide which authority shall be the competent authority, in accordance with the procedure referred to in Article 133(3), and the Member States concerned shall adopt substances for evaluation accordingly. ...

... 1. The Agency shall notify any draft decision under Articles 40, 41 or 46 to the registrant(s) or downstream user(s) concerned, informing them of their right to comment within 30 days of receipt. If the concerned registrant(s) or downstream user(s) wish to comment, they shall provide their comments to the Agency. The Agency in turn shall inform the competent authority of the submission of the comments without delay. The competent authority (for decisions taken under Article 46) and the Agency (for decisions taken under Articles 40 and 41) shall take any comments received into account and may amend the draft decision accordingly. ...

... 5. The Agency shall forthwith communicate any proposal for amendment to any registrants or downstream users concerned and allow them to comment within 30 days. The Member State Committee shall take any comments received into account. ...

... (i) the date(s) from which the placing on the market and the use of the substance shall be prohibited unless an authorisation is granted (hereinafter referred to as "the sunset date") which should take into account, where appropriate, the production cycle specified for that use; ...

... 2. Uses or categories of uses may be exempted from the authorisation requirement provided that, on the basis of the existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled. In the establishment of such exemptions, account shall be taken, in particular, of the proportionality of risk to human health and the environment related to the nature of the substance, such as where the risk is modified by the physical form. ...

... 3. Prior to a decision to include substances in Annex XIV, the Agency shall, taking into account the opinion of the Member State Committee, recommend priority substances to be included specifying for each substance the items set out in paragraph 1. Priority shall normally be given to substances with: ...

... The number of substances included in Annex XIV and the dates specified under paragraph 1 shall also take account of the Agency's capacity to handle applications in the time provided for. The Agency shall make its first recommendation of priority substances to be included in Annex XIV by 1 June 2009. The Agency shall make further recommendations at least every second year with a view to including further substances in Annex XIV. ...

... 4. Before the Agency sends its recommendation to the Commission it shall make it publicly available on its website, clearly indicating the date of publication, taking into account Articles 118 and 119 on access to information. The Agency shall invite all interested parties to submit comments within three months of the date of publication, in particular on uses which should be exempt from the authorisation requirement. The Agency shall update its recommendation, taking into account the comments received. ...

... 4. Before the Agency sends its recommendation to the Commission it shall make it publicly available on its website, clearly indicating the date of publication, taking into account Articles 118 and 119 on access to information. The Agency shall invite all interested parties to submit comments within three months of the date of publication, in particular on uses which should be exempt from the authorisation requirement. The Agency shall update its recommendation, taking into account the comments received. ...

... 2. Without prejudice to paragraph 3, an authorisation shall be granted if the risk to human health or the environment from the use of a substance arising from the intrinsic properties specified in Annex XIV is adequately controlled in accordance with section 6.4 of Annex I and as documented in the applicant's chemical safety report, taking into account the opinion of the Committee for Risk Assessment referred to in Article 64(4)(a). When granting the authorisation, and in any conditions imposed therein, the Commission shall take into account all discharges, emissions and losses, including risks arising from diffuse or dispersive uses, known at the time of the decision. The Commission shall not consider the risks to human health arising from the use of a substance in a medical device regulated by Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices⁽¹⁾, Council Directive 93/42/EEC of 14 June 1993 concerning medical devices⁽²⁾or Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices⁽³⁾. ...

... 2. Without prejudice to paragraph 3, an authorisation shall be granted if the risk to human health or the environment from the use of a substance arising from the intrinsic properties specified in Annex XIV is adequately controlled in accordance with section 6.4 of Annex I and as documented in the applicant's chemical safety report, taking into account the opinion of the Committee for Risk Assessment referred to in Article 64(4)(a). When granting the authorisation, and in any conditions imposed therein, the Commission shall take into account all discharges, emissions and losses, including risks arising from diffuse or dispersive uses, known at the time of the decision. The Commission shall not consider the risks to human health arising from the use of a substance in a medical device regulated by Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices⁽¹⁾, Council Directive 93/42/EEC of 14 June 1993 concerning medical devices⁽²⁾or Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices⁽³⁾. ...

... 4. If an authorisation cannot be granted under paragraph 2 or for substances listed in paragraph 3, an authorisation may only be granted if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies. This decision shall be taken after consideration of all of the following elements and taking into account the opinions of the Committee for Risk Assessment and the Committee for Socio-economic Analysis referred to in Article 64(4)(a) and (b): ...

... 5. When assessing whether suitable alternative substances or technologies are available, all relevant aspects shall be taken into account by the Commission, including: ...

... (a) whether the transfer to alternatives would result in reduced overall risks to human health and the environment, taking into account the appropriateness and effectiveness of risk management measures; ...

... 8. Authorisations shall be subject to a time-limited review without prejudice to any decision on a future review period and shall normally be subject to conditions, including monitoring. The duration of the time-limited review for any authorisation shall be determined on a case-by-case basis taking into account all relevant information including the elements listed in paragraph 4(a) to (d), as appropriate. ...

... 1. Authorisations granted in accordance with Article 60 shall be regarded as valid until the Commission decides to amend or withdraw the authorisation in the context of a review, provided that the holder of the authorisation submits a review report at least 18 months before the expiry of the time-limited review period. Rather than re-submitting all elements of the original application for the current authorisation, the holder of an authorisation may submit only the number of the current authorisation, subject to the second, third and fourth subparagraphs. A holder of an authorisation granted in accordance with Article 60 shall submit an update of the analysis of alternatives referred to in Article 62(4)(e), including information about any relevant research and development activities by the applicant, if appropriate, and any substitution plan submitted under Article 62(4)(f). If the update of the analysis of alternatives shows that there is a suitable alternative available taking into account the elements in Article 60(5), he shall submit a substitution plan, including a timetable for proposed actions by the applicant. If the holder cannot demonstrate that the risk is adequately controlled, he shall also submit an update of the socio-economic analysis contained in the original application. If he can now demonstrate that the risk is adequately controlled, he shall submit an update of the chemical safety report. If any other elements of the original application have changed, he shall also submit updates of these element(s). When any updated information is submitted in accordance with this paragraph, any decision to amend or withdraw the authorisation in the context of the review shall be taken in accordance with the procedure referred to in Article 64 applied mutatis mutandis. ...

... 3. In its review decision the Commission may, if circumstances have changed and taking into account the principle of proportionality, amend or withdraw the authorisation, if under the changed circumstances it would not have been granted or if suitable alternatives in accordance with Article 60(5) become available. In the latter case the Commission shall require the holder of the authorisation to present a substitution plan if he has not already done so as part of his application or update. In cases where there is a serious and immediate risk for human health or the environment, the Commission may suspend the authorisation pending the review, taking into account the principle of proportionality. ...

... 3. In its review decision the Commission may, if circumstances have changed and taking into account the principle of proportionality, amend or withdraw the authorisation, if under the changed circumstances it would not have been granted or if suitable alternatives in accordance with Article 60(5) become available. In the latter case the Commission shall require the holder of the authorisation to present a substitution plan if he has not already done so as part of his application or update. In cases where there is a serious and immediate risk for human health or the environment, the Commission may suspend the authorisation pending the review, taking into account the principle of proportionality. ...

... (f) where the analysis referred to in point (e) shows that suitable alternatives are available, taking into account the elements in Article 60(5), a substitution plan including a timetable for proposed actions by the applicant. ...

... 2. The Agency shall make available on its web-site broad information on uses, taking into account Articles 118 and 119 on access to information, for which applications have been received and for reviews of authorisations, with a deadline by which information on alternative substances or technologies may be submitted by interested third parties. ...

... 3. In preparing its opinion, each Committee referred to in paragraph 1 shall first check that the application includes all the information specified in Article 62 that is relevant to its remit. If necessary, the Committees shall, in consultation with each other, make a joint request to the applicant for additional information to bring the application into conformity with the requirements of Article 62. The Committee for Socio-economic Analysis may, if it deems it necessary, require the applicant or request third parties to submit, within a specified time period, additional information on possible alternative substances or technologies. Each Committee shall also take into account any information submitted by third parties. ...

... 5. The Agency shall send these draft opinions to the applicant by the end of the deadline set out in paragraph 1. Within one month of receipt of the draft opinion, the applicant may provide written notice that he wishes to comment. The draft opinion shall be deemed to have been received seven days after the Agency has sent it. If the applicant does not wish to comment, the Agency shall send these opinions to the Commission, the Member States and the applicant, within 15 days of the end of the period within which the applicant may comment or within 15 days of receipt of notice from the applicant that he does not intend to comment. If the applicant wishes to comment, he shall send his written argumentation to the Agency within two months of the receipt of the draft opinion. The Committees shall consider the comments and adopt their final opinions within two months of receipt of the written argumentation, taking this argumentation into account where appropriate. Within a further 15 days the Agency shall send the opinions, with the written argumentation attached, to the Commission, the Member States and the applicant. ...

... 1. When there is an unacceptable risk to human health or the environment, arising from the manufacture, use or placing on the market of substances, which needs to be addressed on a Community-wide basis, Annex XVII shall be amended in accordance with the procedure referred to in Article 133(4) by adopting new restrictions, or amending current restrictions in Annex XVII, for the manufacture, use or placing on the market of substances on their own, in preparations or in articles, pursuant to the procedure set out in Articles 69 to 73. Any such decision shall take into account the socio-economic impact of the restriction, including the availability of alternatives. The first subparagraph shall not apply to the use of a substance as an on-site isolated intermediate. ...

... Within nine months of the date of publication referred to in Article 69(6), the Committee for Risk Assessment shall formulate an opinion as to whether the suggested restrictions are appropriate in reducing the risk to human health and/or the environment, based on its consideration of the relevant parts of the dossier. This opinion shall take account of the Member State dossier or of the dossier prepared by the Agency at the request of the Commission, and the views of interested parties referred to in point (a) of Article 69(6). ...

... 1. Within 12 months of the date of publication referred to in Article 69(6), the Committee for Socio-economic Analysis shall formulate an opinion on the suggested restrictions, based on its consideration of the relevant parts of the dossier and the socio-economic impact. It shall prepare a draft opinion on the suggested restrictions and on the related socio-economic impact, taking account of the analyses or information according to point (b) of Article 69(6), if there are any. The Agency shall publish the draft opinion on its website without delay. The Agency shall invite interested parties to give their comments on the draft opinion no later than 60 days from the publication of that draft opinion. ...

... 2. The Committee for Socio-economic Analysis shall without delay adopt its opinion, taking into account where appropriate further comments received by the deadline set. This opinion shall take account of the comments and socio-economic analyses of interested parties submitted under point (b) of Article 69(6) and under paragraph 1 of this Article. ...

... 2. The Committee for Socio-economic Analysis shall without delay adopt its opinion, taking into account where appropriate further comments received by the deadline set. This opinion shall take account of the comments and socio-economic analyses of interested parties submitted under point (b) of Article 69(6) and under paragraph 1 of this Article. ...

... 1. If the conditions laid down in Article 68 are fulfilled, the Commission shall prepare a draft amendment to Annex XVII, within three months of receipt of the opinion of the Committee for Socio-economic Analysis or by the end of the deadline established under Article 71 if that Committee does not form an opinion, whichever is the earlier. Where the draft amendment diverges from the original proposal or if it does not take the opinions from the Agency into account, the Commission shall annex a detailed explanation of the reasons for the differences. ...

... 3. The structure and amount of the fees referred to in paragraph 1 shall take account of the work required by this Regulation to be carried out by the Agency and the competent authority and shall be fixed at such a level as to ensure that the revenue derived from them when combined with other sources of the Agency's revenue pursuant to Article 96(1) is sufficient to cover the cost of the services delivered. The fees set for registration shall take into account the work that may be done pursuant to Title VI. In the case of Article 6(4), Article 7(1) and (5), Article 9(2), Article 11(4), Article 17(2) and Article 18(2), the structure and amount of fees shall take account of the tonnage range of the substance being registered. In all cases, a reduced fee shall be set for SMEs. In the case of Article 11(4), the structure and amount of fees shall take into account whether information has been submitted jointly or separately. In the case of a request made under Article 10(a)(xi), the structure and amount of fees shall take into account the work required by the Agency in assessing the justification. ...

... 3. The structure and amount of the fees referred to in paragraph 1 shall take account of the work required by this Regulation to be carried out by the Agency and the competent authority and shall be fixed at such a level as to ensure that the revenue derived from them when combined with other sources of the Agency's revenue pursuant to Article 96(1) is sufficient to cover the cost of the services delivered. The fees set for registration shall take into account the work that may be done pursuant to Title VI. In the case of Article 6(4), Article 7(1) and (5), Article 9(2), Article 11(4), Article 17(2) and Article 18(2), the structure and amount of fees shall take account of the tonnage range of the substance being registered. In all cases, a reduced fee shall be set for SMEs. In the case of Article 11(4), the structure and amount of fees shall take into account whether information has been submitted jointly or separately. In the case of a request made under Article 10(a)(xi), the structure and amount of fees shall take into account the work required by the Agency in assessing the justification. ...

... 3. The structure and amount of the fees referred to in paragraph 1 shall take account of the work required by this Regulation to be carried out by the Agency and the competent authority and shall be fixed at such a level as to ensure that the revenue derived from them when combined with other sources of the Agency's revenue pursuant to Article 96(1) is sufficient to cover the cost of the services delivered. The fees set for registration shall take into account the work that may be done pursuant to Title VI. In the case of Article 6(4), Article 7(1) and (5), Article 9(2), Article 11(4), Article 17(2) and Article 18(2), the structure and amount of fees shall take account of the tonnage range of the substance being registered. In all cases, a reduced fee shall be set for SMEs. In the case of Article 11(4), the structure and amount of fees shall take into account whether information has been submitted jointly or separately. In the case of a request made under Article 10(a)(xi), the structure and amount of fees shall take into account the work required by the Agency in assessing the justification. ...

... 3. The structure and amount of the fees referred to in paragraph 1 shall take account of the work required by this Regulation to be carried out by the Agency and the competent authority and shall be fixed at such a level as to ensure that the revenue derived from them when combined with other sources of the Agency's revenue pursuant to Article 96(1) is sufficient to cover the cost of the services delivered. The fees set for registration shall take into account the work that may be done pursuant to Title VI. In the case of Article 6(4), Article 7(1) and (5), Article 9(2), Article 11(4), Article 17(2) and Article 18(2), the structure and amount of fees shall take account of the tonnage range of the substance being registered. In all cases, a reduced fee shall be set for SMEs. In the case of Article 11(4), the structure and amount of fees shall take into account whether information has been submitted jointly or separately. In the case of a request made under Article 10(a)(xi), the structure and amount of fees shall take into account the work required by the Agency in assessing the justification. ...

... 3. The structure and amount of the fees referred to in paragraph 1 shall take account of the work required by this Regulation to be carried out by the Agency and the competent authority and shall be fixed at such a level as to ensure that the revenue derived from them when combined with other sources of the Agency's revenue pursuant to Article 96(1) is sufficient to cover the cost of the services delivered. The fees set for registration shall take into account the work that may be done pursuant to Title VI. In the case of Article 6(4), Article 7(1) and (5), Article 9(2), Article 11(4), Article 17(2) and Article 18(2), the structure and amount of fees shall take account of the tonnage range of the substance being registered. In all cases, a reduced fee shall be set for SMEs. In the case of Article 11(4), the structure and amount of fees shall take into account whether information has been submitted jointly or separately. In the case of a request made under Article 10(a)(xi), the structure and amount of fees shall take into account the work required by the Agency in assessing the justification. ...

... (g) liaising with industry, taking particular account of the specific needs of SMEs, and other stakeholders, including relevant international organisations, as necessary; ...

... (c) the draft annual accounts; ...

... 3. By 1 March at the latest following each financial year, the Agency's accounting officer shall communicate the provisional accounts to the Commission's accounting officer together with a report on the budgetary and financial management for that financial year. The Commission's accounting officer shall consolidate the provisional accounts of the institutions and decentralised bodies in accordance with Article 128 of Regulation (EC, Euratom) No 1605/2002. ...

... 3. By 1 March at the latest following each financial year, the Agency's accounting officer shall communicate the provisional accounts to the Commission's accounting officer together with a report on the budgetary and financial management for that financial year. The Commission's accounting officer shall consolidate the provisional accounts of the institutions and decentralised bodies in accordance with Article 128 of Regulation (EC, Euratom) No 1605/2002. ...

... 4. By 31 March at the latest following each financial year, the Commission's accounting officer shall forward the Agency's provisional accounts to the Court of Auditors, together with a report on the budgetary and financial management for that financial year. The report on the budgetary and financial management for that financial year shall also be forwarded to the European Parliament and the Council. ...

... 5. On receipt of the Court of Auditors' observations on the Agency's provisional accounts, pursuant to Article 129 of Regulation (EC, Euratom) No 1605/2002, the Executive Director shall draw up the Agency's final accounts under his own responsibility and forward them to the Management Board for an opinion. ...

... 5. On receipt of the Court of Auditors' observations on the Agency's provisional accounts, pursuant to Article 129 of Regulation (EC, Euratom) No 1605/2002, the Executive Director shall draw up the Agency's final accounts under his own responsibility and forward them to the Management Board for an opinion. ...

... 6. The Management Board shall deliver an opinion on the Agency's final accounts. ...

... 7. By 1 July of the following year at the latest, the Executive Director shall send the final accounts, together with the opinion of the Management Board, to the European Parliament, the Council, the Commission and the Court of Auditors. ...

... 8. The final accounts shall be published. ...

... 2014. When carrying out the review the Commission shall take into account all relevant factors, including: ...

... (b) the need, if any, to register certain types of polymer, taking account of competitiveness and innovation on the one hand and the protection of human health and the environment on the other. ...

... 3. The report, referred to in Article 117(4), on the experience acquired with the operation of this Regulation shall include a review of the requirements relating to registration of substances manufactured or imported only in quantities starting at 1 tonne but less than 10 tonnes per year per manufacturer or importer. On the basis of that review, the Commission may present legislative proposals to modify the information requirements for substances manufactured or imported in quantities of 1 tonne or more up to 10 tonnes per year per manufacturer or importer, taking into account the latest developments, for example in relation to alternative testing and (quantitative) structure-activity relationships ((Q)SARs). ...

... 7. By 1 June 2013 the Commission shall carry out a review to assess whether or not, taking into account latest developments in scientific knowledge, to extend the scope of Article 60(3) to substances identified under Article 57(f) as having endocrine disrupting properties. On the basis of that review the Commission may, if appropriate, present legislative proposals. ...

... 8. By 1 June 2019, the Commission shall carry out a review to assess whether or not to extend the scope of Article 33 to cover other dangerous substances, taking into account the practical experience in implementing that Article. On the basis of that review, the Commission may, if appropriate, present legislative proposals to extend that obligation. ...